KPI HEALTHCARE, INC.

KPI HEALTHCARE, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose Oxidase, Glucose (CGA) (7) System, Test, Blood Glucose, Over The Counter (NBW) (5) Assay, Glycosylated Hemoglobin (LCP) (4) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (4) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (3) Ldl & Vldl Precipitation, Hdl (LBR) (3) Colorimetric Method, Triglycerides (JGY) (3) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Glucose Dehydrogenase, Glucose (LFR) (1)

Premarket Exempt

No

Clear

CURO A1c - 00850006113026 Catalog Number :

Device Description : CURO A1c Monthly Check Cartridge

Device Class :

Duns Number: 087243403

Premarket Exempt : No

Product Code : LCP, CGA

Prescription Use : No

Device Count : 10

CURO A1c - 00850006113033 Catalog Number :

Device Description : Curo A1c Test Cartridge

Device Class :

Duns Number: 087243403

Premarket Exempt : No

Product Code : CGA, LCP

Prescription Use : No

Device Count : 10

CURO A1c - 00850006113040 Catalog Number :

Device Description : CURO A1c Daily Check Cartridge

Device Class : 2

Duns Number: 087243403

Premarket Exempt : No

Product Code : CGA, LCP

Prescription Use : No

Device Count : 1

Curo L5 - 00850006113064 Catalog Number :

Device Description : CURO L5 Glucose Strip

Device Class :

Duns Number: 087243403

Premarket Exempt : No

Product Code : LBR, JJX, JGY, CHH, CGA, NBW

Prescription Use : No

Device Count : 50

CURO L5 - 00860394001225 Catalog Number :

Device Description : CURO L5 Cholesterol and Glucose measuring system

Device Class : 1

Duns Number: 087243403

Premarket Exempt : No

Product Code : NBW, CGA, CHH, JGY, JJX, LBR

Prescription Use : No

Device Count : 1

CURO B3 - 00860394001232 Catalog Number :

Device Description : CURO B3 Blood Pressure Monitor

Device Class : 2

Duns Number: 087243403

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

CURO G6s Smart Glucose Meter - 00860394001249 Catalog Number :

Device Description : CURO G6s Smart Glucose Meter

Device Class : 2

Duns Number: 087243403

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

CURO L5 Total Cholesterol Strips - 00860394001256 Catalog Number :

Device Description : Total Cholesterol Strips

Device Class :

Duns Number: 087243403

Premarket Exempt : No

Product Code : NBW, CGA, CHH, JGY, JJX, LBR

Prescription Use : No

Device Count : 10

CURO G6 Glucose Meter - 00860394001263 Catalog Number :

Device Description : CURO G6 Glucose Meter

Device Class : 1

Duns Number: 087243403

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

Curo A1c Analyzer - 00860394001270 Catalog Number :

Device Description : Curo A1c Analyzer

Device Class : 2

Duns Number: 087243403

Premarket Exempt : No

Product Code : CGA, LCP

Prescription Use : No

Device Count : 1

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